AlloVir has reported positive long-term, follow-up data from the Phase ll trial of multi-virus T cell therapy posoleucel to prevent clinically significant infections caused by six common viruses in the recipients of allogeneic hematopoietic cell transplant (allo-HCT).
Data showed that the high-risk allo-HCT patients treated with posoleucel experienced sustained low rates of clinically vital infections and end-organ disease, as well as 0% non-relapse mortality.
The Phase ll open-label trial examined the therapy’s efficacy and safety to prevent clinically significant viral infections and disease from six target viruses, AdV, BKV, CMV, EBV, HHV-6 and JCV.
It included both prophylaxes of patients at high risk for viral reactivation and the preemptive treatment of viral reactivation patients who were yet to develop clinically important infections or diseases.
During the trial, patients were given up to seven biweekly posoleucel infusions. They were also tested for viremia by polymerase chain reaction (PCR) every week against all six viruses for 14 weeks.
Following the completion of this dosing period, patients were followed through week 26.
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By GlobalDataThe trial’s primary endpoint was the number of new-onset infections or end-organ diseases through week 14.
Furthermore, the trial included a 52-week follow-up visit.
The new findings also showed that out of the 26 patients who received posoleucel, five deaths were related to relapse/progression of underlying disease.
None of the deaths occurred due to infection or was deemed related to the treatment, thereby resulting in 0% non-relapse mortality.
AlloVir CEO Diana Brainard said: “The data presented today provide further evidence supporting the potential benefits of using posoleucel to prevent viral infection in high-risk allo-HCT patients.
“The non-relapse mortality rate in patients receiving posoleucel was 0% through week 52 which compares favourably with published non-relapse mortality rates among allo-HCT patients ranging from 9% to over 15%.
“Our global, registrational Phase lll clinical trial further exploring the potential of posoleucel for multi-virus prevention is well underway and we anticipate data from this registrational study in 2024.”
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